WASHINGTON, D.C. – AdvaMed released a statement on FDA’s announcement today that the agency is concerned about medical device shortages in light of two recent closures of ethylene oxide sterilization…
WASHINGTON, D.C. – This week, six leading medical groups sent a letter to FDA urging caution as regulators consider limiting the use of ethylene oxide (EtO) for medical device sterilization. The surgeons…
This document provides successful practices for the development, manufacture, and use of batteries in medical device applications
Medical device manufacturers take seriously the need to continuously assess the security of their devices.